A Global, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Adults Aged 18 Years and Older

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
Hangzhou Tigermed Consulting Co., Ltd., and PT Equilab International
No Registry
INA-F7MRQNA
Tanggal Input Registry : 25-04-2024

01-11-2021
To evaluate the efficacy of the recombinant SARS CoV 2 fusion protein vaccine (V 01) for the prevention of symptomatic RT PCR positive COVID 19 (mild or above in severity) starting from more than 14 days after full course immunization (completing all vaccinations)
To evaluate the efficacy of the recombinant SARS CoV 2 fusion protein vaccine (V 01) for the prevention of COVID 19 of severe or above in severity starting from more than 14 days after full course.
 
A Global, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Adults Aged 18 Years and Older
A Global, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Adults Aged 18 Years and Older
Interventional
Recombinant SARS CoV 2 fusion protein vaccine (V 01)
5500
 

Inclusion Criteria:

1. Voluntarily participate in this study and sign the informed consent form, 2. Adults aged 18 years and older, male or female, 3. According to the assessment of the investigator, the participant has a stable medical condition (which is defined as no significant changes in therapy or hospitalization caused by disea se aggravation within 3 months before enrollment) or the healthy participant, and the participant is able to and willing to follow the requirements of the protocol, 4. Males of reproductive potential and females of child bearing potential voluntarily agree to take effective and acceptable contraceptive methods from the signing of informed consent form to 3 months a fter full course immunization; females of child bearing potential have negative pregnancy test at screening and at the day of vaccination, Female participants of non childbearing potential may be enrolled in the study. Non childbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to screening without an alternative medical cause)

Exclusion Criteria:

1. History of previous COVID 19; 2. The result for RT PCR test or specific antibody IgG or IgM against SARS CoV 2 in the screening period meet the following conditions, 1) If IgG is positive, the participant will be excluded regardless of the results of other indexes. 2) If IgG is negative and IgM is positive, it will be determined whether or not to enroll such participant after the result of RT PCR test is obtained. 3) If both IgG and IgM are negative, the participant can be vaccinated without waiting for the RT PCR test result. 4 If the RT PCR test result is positive prior to vaccination, the participant will be excluded regardless of the results of IgG or IgM 3. History of severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS) and other human coronavirus infections or diseases; 4. History of severe allergy to any vaccine, e.g., acute allergic reactions, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain etc., or be allergic to any components of V 01, 5. Any confirmed or suspected immunosuppression or immunodeficiency condition known from medical history, including human immunodeficiency virus infection, asplenia, 6. Serious or uncontrolled cardiovascular diseases, nervous system disorders (e.g., Guillain Barre syndrome), blood and lymphatic system disorders, immune system disorders, hepatorenal disorders, respiratory system disorders (e.g., active tuberculosis, pulmonary fibrosis), metabolic and skeletal systems disorders or malignant tumors (except for skin basal cell carcinoma or in situ carcinoma of uterine cervix that has been cured more than 5 years), 7. Hereditary hemorrhagic tendency or coagulation dysfunction, or a history of thrombosis or hemorrhagic disease, or requirement of continuous use of anticoagulants, 8. Prior use of any medications to prevent COVID 19 within 1 week before signing the informed consent form e.g., use of antipyretics without pyrexia and any other symptoms, 9. History of vaccination against SARS CoV 2 (marketed or investigational), 10. Received attenuated live vaccine within 28 days before the first vaccination or any other vaccines (licensed or investigational) within 14 days before the first vaccination; 11. Injection of immunoglobulin and/or other blood products within 3 months before the administration of investigational vaccine, 12. Long term use (continuous use >14 days) of glucocorticoids 10 mg/day of prednisone or its equivalent dose) or other immunosuppressive agents within 6 month s before signing the informed consent form ; however, enrollment is allowed for the following conditions: inhale d or topical use of topical steroids, or short term use (treatment course 14 days) of oral steroids, 13. Pregnant or breastfeeding women, 14. Planning to donate blood during the study period, 15. Suspected or known alcohol or drug dependence, 16. History of severe psych iatric disorders which may affect study participation, 17. Planning to permanently move from the local area before study completion or leave the local area for a long time during the period of study visits, so that the scheduled visits cannot be followed, 18. Those considered by the investigator as inappropriate to participate in the study
 
Nomor: 736/UN6.KEP/EC/2021
MTA number
PPUK/PPUB number
DR. Dr. Bachti Alisjahbana, SpPD (K)PTI, MD, PhD